Lupin has announced the launch of Azilsartan Medoxomil Tablets, 40 mg and 80 mg, in the United States following approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA).
The company stated that the product is bioequivalent to Edarbi of Azurity Pharmaceuticals, Inc. and is indicated for the treatment of hypertension in adults to lower blood pressure.
Lupin is the exclusive first-to-file for the product and is eligible for 180-day generic drug exclusivity.
According to IQVIA MAT April 2026 data, Azilsartan Medoxomil Tablets (RLD Edarbi) recorded estimated annual sales of USD 53.5 million in the United States.